The microproof® SARS-CoV-2 Screening/Identification Kits* are one-step reverse transcription real-time PCR assays intended for the in vitro qualitative detection of SARS-CoV-2 to support the diagnosis of COVID-19.
The microproof® SARS-CoV-2 Screening Kit detects the E gene (E) for Betacoronavirus, while the microproof® SARS-CoV-2 Identification Kit only targets the SARS-CoV-2 specific RNA-dependent RNA polymerase (RdRp) gene.
The E gene assay is recommended to screen for SARS-CoV-2, SARS-CoV and other SARS-related CoVs. The RdRp gene assay is used for the specific confirmation of SARS-CoV-2. For the E gene and RdRp, the fluorescence marker FAM is used, and ROX for the internal control. MS2 DNA or an MS2 phage are included in the kits as internal controls and as process controls.
Patient RNA samples can be extracted and purified using the BIOTECON Diagnostics’ Magnetic Preparation Kit VI from upper and lower respiratory specimen swabs (such as nasopharyngeal or oropharyngeal, sputum and bronchoalveolar lavage fluid) obtained from individuals suspected of having respiratory tract infections.
*The microproof® SARS-CoV-2 Screening/Identification Kits, based on the WHO & KCDC reference method and adapted according to the Charité (Berlin, Germany) protocol, have been approved “for research use only” for the detection of SARS-CoV-2.
Clinical specimens, including upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum and bronchoalveolar lavage fluid) obtained from individuals suspected of respiratory tract infections.
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